NCT02177903

Brief Summary

The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets. Subjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways:

  • Increased comfort in the pre-operative period by being warmer
  • Decreased incidence of mild hypothermia
  • Possible decreased incidence of transfusion with less bleeding
  • Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)
  • Possible shorter stay in the PACU and overall Length of Stay (LOS)
  • Possible decreased risk for surgical site infection

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

June 25, 2014

Last Update Submit

September 30, 2024

Conditions

Hypothermia

Keywords

hypothermiasurgical site infectionopioid usageblood losspain severityanxietyLength of Stay

Outcome Measures

Primary Outcomes (1)

  • Duration of hypothermia

    The primary endpoint is duration of hypothermia as measured by the area under the curve (AUC). This is achieved by recording patient temperature readings continuously from baseline (prior to initiation of 30 minutes if active or passive pre-warming) until PACU discharge.

    Up to 12 hours, until PACU discharge

Study Arms (2)

Bair PawsPatient Adjustable Warming System

OTHER

Bair PawsPatient Adjustable Warming System for active pre-warming

Device: Bair Paws Patient Adjustable Warming System

Passive pre-warming

OTHER

Passive pre-warming

Device: Bair Paws Patient Adjustable Warming System

Interventions

Bair Paws Patient Adjustable Warming SystemDEVICE

Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.

Also known as: Bair Paws Flex Gown
Bair PawsPatient Adjustable Warming SystemPassive pre-warming

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective or "urgent" surgery under general anesthesia
  • ≥19 years but ≤85 years of age
  • Able to provide informed consent.

You may not qualify if:

  • Refusal of Informed consent
  • Metabolic derangement/drug therapy already affecting thermal homeostasis
  • Preexisting hypothermia (\<35.5 degreeC) or hyperthermia (\>37.5 degreeC) (oral)
  • Surgical procedure anticipated to be longer than 6 hours or less than 1 hour
  • Emergency (category 1a) Surgery
  • Patients undergoing exclusively spinal or epidural anesthesia
  • Patients receiving aortic cross-clamping
  • Patients receiving transdermal medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Columbian Hospital

Vancouver, British Columbia, V3L 3W7, Canada

Location

Related Publications (1)

  • Lau A, Lowlaavar N, Cooke EM, West N, German A, Morse DJ, Gorges M, Merchant RN. Effect of preoperative warming on intraoperative hypothermia: a randomized-controlled trial. Can J Anaesth. 2018 Sep;65(9):1029-1040. doi: 10.1007/s12630-018-1161-8. Epub 2018 Jun 5.

    PMID: 29872966DERIVED

MeSH Terms

Conditions

HypothermiaSurgical Wound InfectionHemorrhagePainAnxiety Disorders

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesNeurologic ManifestationsMental Disorders

Study Officials

  • Richard Merchant, MD

    Staff Anesthesiologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2014

First Posted

June 30, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations

CA(1)